Serve as a member of the R&D team and execute the design of parts, assemblies, and enclosures for new and revised Defibrillator and Ventilator products or sub systems. Collaborate with a cross functional team of engineers and scientists in support of fluid flow, thermal management, ingress protection, EMI isolation, and shock/vibration control per defined product goals. Apply good design practices, procedures, and design criteria in the development of assemblies and subsystems. Layout and develop new product designs. Complete engineering mechanics analysis and tolerance analysis. Complete design refinement to support Design for Manufacture and Assembly objectives. Create detailed design documentation of new and revised products including part drawings, assembly documents, Bills of Materials, and purchasing specifications. Create Engineering Change Orders to enable control and release of designs to production under the ZOLL Quality System. Support document preparation for test and regulatory submission of new/existing designs. Support development of risk assessments and FMEA for creation of the design history file. Lead and participate in technical design reviews for new or revised products and other projects as assigned. Present new designs to suppliers and evaluate samples and prototypes for build and test. Conduct part, subsystem, and system verification and validation testing of new designs complete with supporting documentation. Conduct laboratory testing of new and legacy products and document results. Support management activity in preparation of schedule, budget, and project reporting. Position is fixed location based in Irvine office; however, telecommuting from a home office may also be allowed two (2) days a week. Up to 15% travel, international and domestic for supplier and contract manufacturer visits, business meetings, training and seminars.

40 hours/week, 9:00am-5:00pm
Six (6) years of experience in mechanical engineering and product design. Experience must include:

Six (6) years of experience in the following (experience may be gained concurrently):

- Utilizing Minitab for Design of Experiments testing and analysis.

- Utilizing GD&T in the design and tolerance analysis of complete assemblies and sub-assemblies.

- SolidWorks including Design, Drawing, and PDM.

- GD&T and drawing creation per ASME Y 14.5 2009.

- Design, document and analyze parts encountered in packaging of embedded systems (such as molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables and labels).

Four (4) years of experience in the following (experience may be gained concurrently):

- Molded plastic part design, injection mold design, and materials knowledge including qualification and specification.

- Designing enclosures and assemblies to pass mechanical testing including shock/vibration, water ingress, and impact.

Three (3) years of experience in the following (experience may be gained concurrently):

- SolidWorks Simulation and Structural/Thermal/Flow modelling and analysis.

- Pneumatic/compressor driven systems.

Two (2) years of experience in the following (experience may be gained concurrently):

- Using and programming vision systems for automated part measuring and inspection.

One (1) year of experience in the following (experience can be gained concurrently)

- Medical product development or other highly regulated environments (ISO requirements, GMP/GDP guidelines, FDA regulations, International regulation, and medical device design control)

- Respiratory breathing systems, heated humidifiers, and ventilators.
Requires a Masters degree (or foreign equivalent) in Mechanical Engineering or a directly related field
Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at (link removed) with reference in the subject line.

Thank you.